PrepStain Tecan US-I. For use in the screening and recall
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
Why was PrepStain Tecan US-I. For use in the screening and recalled?
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Numbers - 799-13000-00 and 799-13000-00R
- Product
- PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 890 instruments
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
- Recall date
- September 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)